Single Ascending Dose Study of WAL0921 in Healthy Subjects

Safety, Pharmacokinetics, and Pharmacodynamics of a Single, Ascending Dose of WAL0921 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05891366

Enrollment

Registered

2023-06-06

Start date

2023-05-31

Completion date

2024-01-09

Last updated

2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in healthy subjects.

Interventions

DRUGWAL0921

Investigational product WAL0921

DRUGPlacebo

Placebo product

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing 2. Healthy individuals without known current or chronic medical conditions in the opinion of the Investigator 3. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2

Exclusion criteria

1. Clinically significant findings in physical examination, vital signs (blood pressure, heart rate, and body temperature), ECG, and safety laboratory parameters at screening in the opinion of the Investigator 2. Renal function calculated by the CKD-EPI (2021) equation with eGFR \<90 mL/min/1.73 m2 at the time of screening 3. Abnormal levels of proteinuria detected on Urine Protein-Creatinine Ratio (UPCR) test \>0.30 g/g 4. Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems

Design outcomes

Primary

Measure	Time frame
Incidence of treatment emergent adverse events	Day 1 to Day 64

Secondary

Measure	Time frame	Description
Number of participants with clinically significant changes in chemistry lab values	Day 64	Chemistry labs include a comprehensive metabolic panel
AUC	Day 1 to Day 64	Area Under the Drug Concentration-Time Curve
Cmax	Day 1 to Day 64	Maximum Observed Drug Concentration
Number of participants with clinically significant changes in hematology lab values	Day 64	Hematology labs include complete blood count with differential and coagulation panel
Half-life	Day 1 to Day 64	Drug terminal elimination half-life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026